Regulatory Submissions Ass Manager II

Job Description We are looking for a Regulatory Submissions Ass Manager II to support global and regional clinical trials through high‑quality regulatory submissions across Europe and beyond. This role plays a critical part in ensuring timely approvals, regulatory compliance, and successful study start‑up, with a strong focus on EU Clinical Trial Regulation (CTR) and CTIS operations. You will work in a matrix, client‑facing environment, collaborating closely with project teams, start‑up leads, local regulatory teams, and external authorities. Key Responsibilities - Own and manage Regulatory Authority (RA), IRB/EC, and Third Body submissions for assigned clinical trials, including: - Submission strategy, planning, and timeline management - Tracking approvals against project milestones (GL, RTE) - Coordinating responses to authority queries within defined timelines - Lead or support EU CTR submissions via CTIS, including: - Preparation, submission, and maintenance of CTIS applications - Managing CTIS user access and acting as CTIS back‑up when required - Advising internal teams on CTR/CTIS processes and expectations - Prepare, review, and quality‑check core regulatory packages and country‑specific submission packages - Ensure all deliverables comply with applicable regulations, guidance, SOPs, and client requirements - Provide regulatory guidance to project teams by maintaining up‑to‑date knowledge of global and EU regulatory requirements - Liaise with or support local teams in communications with Regulatory Authorities, Ethics Committees, and Third Bodies - Identify and proactively escalate risks to timelines, quality, or approvals - Support audits, inspections, and resolution of findings - Contribute to process improvement initiatives, including SOP development and optimization - Mentor junior team members and support overall team capability building Required Qualifications & Experience - Bachelor’s degree in Life Sciences or a related field (or equivalent experience) - Minimum 4 years of experience in Regulatory Affairs, Regulatory Submissions, or Clinical Trial Start‑Up within pharma, biotech, or CRO - Hands‑on experience with EU CTR and CTIS is required, including: - Preparing and submitting applications in CTIS - Managing CTIS workflows, timelines, and user access - Responding to CTIS‑related authority questions - Solid understanding of RA, IRB/EC, and Third Body submission processes - Experience supporting global or regional clinical trials - Strong organizational skills with the ability to manage multiple submissions and deadlines - Confident communicator able to work with cross‑functional and client stakeholders Learn more about our EEO & Accommodations request here. Originally posted on Himalayas